“Validation is required, as regulated by FDA, to ensure that a company’s product development software/system will meet its intended purpose. The software/system must show that it will function in a reliable, consistent manner and is in compliance with regulatory and business requirements. Additionally, once the software/system has been accepted and released for use, there is a need to maintain compliance and fitness throughout its operational life. Unfortunately, information on how to develop a validation plan and the activities expected as part of a validation effort are limited and subject to misinterpretation.” Are you struggling with finding a fully validated Requirements Management Tool? If so, check out the full white paper by Cognition!

Successful companies are constantly fine-tuning existing products and planning new ones. But even the most ambitious businesses can suffer when critical projects get backed up in the pipeline. Management at Chicago-based Rauland-Borg Corporation realized its good intentions were being subverted by the lack of effective project portfolio management (PPM), and decided to do something about it. Check out the full case study to discover the four step approach to solving complex development projects.

Winning the game requires you to manage the details in short increment time intervals. For a fast/short cycle time business, if you learned that you missed the day at the end of the day, it’s too late to do much about it. But if you had the ability to measure and address performance in hourly or shorter time frames, there’s time to take action to ensure you meet the day’s goals. To learn more about data-driven daily management, check out this eguide by Dploy Solutions!

Sonoco ThermoSafe, a unit of Sonoco (NYSE:SON) and a leading global provider of temperature assurance packaging, leverages award winning technology to expand its line of pallet solutions with the launch of the LD7 Half PAG pallet shipper. The Half PAG solution is designed to ship multiple pallet loads, while reducing the cost and operational complexity of bulk shipments by optimizing the use of aircraft ULDs (LD7 air pallets). The Half PAG is available for 2-8°C or 15-25°C temperature ranges with durations in excess of five days. Each solution has a universal pack-out design to be used in both hot and cold seasons while also accommodating the demands of cross-hemispheric shipments. To learn more about LD7 Half PAG Pallet Shippers, Check out this article by Sonoco!

Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons. To learn more about qualified temperature controlled shippers, check out this article by Sonoco!

Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits: To learn more about smart outsourcing and what the operational and business benefits are, check out this white paper by OQSIE

In your experience, what has the outcome been like when an organization has taken the time to improve its’ single-use strategy? The first thing people sigh in relief about is that there is no danger of breathing in particles and that they are dispersing all over the manufacturing facility. Once the system is closed, there is no longer so much time spent on cleaning and validation. In addition, it helps speed up the process making it so there is one less bottleneck on the road to continuous manufacturing. To learn more about single-use strategy and make sure you are including everything you need, check out the full ebook by ILC Dover below!

In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below!

Today, manufacturers are optimizing open-suite facility design to maximize throughput and profitability. Key to this initiative is minimizing product loss due to feedstock spills, waste and cross contamination. Improving the safety of workers is also a driving factor, through reduced exposure 10 to airborne particles and lowering the risk of particle ignition. In order to accomplish both, a highly efficient powder transfer and containment system is required — one that is designed exclusively for powders, not one adapted from a liquid transfer system. The EZ BioPac® single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. It is suitable for a wide range of filling/ dispensing volumes, flow rates, and product weights. Plus, its rugged, disposable transfer bags feature anti-static properties, assuring fast, complete discharge into process vessels. Want to learn more about the EZ BioPac Single-Use Powder Transfer and how it can boost profits? Check out the white paper from ILC Dover below!

Many biopharmaceutical manufacturers are Implementing single-use containment and transfer of media and buffer materials to prevent feedstock contamination and to promote worker safety. Choosing the proper containment system can have a significant impact on productivity and profitability.Solutions such as the EZ BioPac® system from ILC Dover® lessens the amount of powder that disperses into the air substantially, thereby lowering the risk of cross-contamination. Reducing the amount of contamination, in turn, reduces the time needed for changeover, lowers staff costs, and frees staff to work on more vital jobs, which all contribute to profitability. Want to learn more about single use powder transfer? Read more in the white paper by ILC Dover below!